Food, Drug, And Cosmetics Act 2013

7/27/2019 Food, Drug, And Cosmetics Act 2013

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CHAPTER VIProhibited Acts and Penalties

Sec. 11. The following actsand the causing thereof arehereby prohibited:

a. The manufacture, sale,

offering for sale or transfer ofany food, drug, of any food,drugs, of cosmetic that isadulterated ormisbranded.

b. The adulteration or

misbranding of any food,drug, device or cosmetic.

c. The refusal to permitentry or inspection asauthorized by Sectiontwenty-seven hereof or to

follow samples to becollected.


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Prohibited Actse. Forging,

counterfeiting,simulating, or falselyrepresenting or withoutproper authority using anymark, stamp, tag label, orother identification deviceauthorized or required by

regulations

f. The using by any personto his own advantage, orreveling, other than to theSecretary or officers or

employees of theDepartment or to thecourts when relevant in anyjudicial proceeding underthis Act, any informationacquired under authority ofSection nine, or concerningany method or process


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Prohibited Actsg. The alteration, mutilation,destruction, obliteration, orremoval of the whole or anypart of the labeling of, or thedoing of any other act withrespect to, a food, drug,device, or cosmetic, if such actis done while such article is heldfor sale (whether or not the firstsale) and results in such articlebeing adulterated or misbranded.

h. The use, on the labeling ofany drug or in any advertisingrelating to such drug, of anyrepresentation or suggestionthat an application with

respect to such drug is effectiveunder Section twenty-one hereof,or that such drug complies withthe provisions of such section.

i. The use, in labeling,advertising or other sales

promotion of any reference toany report or analysis furnished


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PenaltiesSec. 12. (a) upon conviction, be subject to

imprisonment ofnot less than six monthsand one day, but not more than fiveyears, or a fine of not less than onethousand pesos, or both suchimprisonment and fine


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AdulteratedMisbranded

Unsanitarypreparation,

Has a hazardouscomponentadded, oressential

componentremoved,

Poisonous,

Illegalcom onent

Labeling is false ormisleading

Label does not containname and place ofbusiness of the

manufacturer, Inaccurate statement of

the quantity of thecontents in terms ofweight, measure, ornumerical count

Its container is so made,formed, or filled as to bemisleading;

Any word, statement, orother informationrequired to appear on the


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Definitions andStandards forFood


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HONG KONG Cypriot

inspectors found arsenicin the frozen calamari. TheItalians discovered

maggots in the pasta.There were glass chipsin the pumpkin seedsbound for Denmark, andSpanish regulators blocked ashipment of frozen duck meat

because of forgedpapers. It has been arough year for Chinese food

exports to Europe.


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Misbranded food


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Controla. The Secretary after investigation in domestic

commerce of any class of food may be injurious to

health, and cannot be adequately determined aftersuch articles have entered domestic commerce, canpromulgate regulations of the manufacture,processing, or packaging of these products andstop the sale and manufacture of these productsuntil the manufacturer can meet the standardsof the Secretary

b. The Secretary can suspend immediately anypermit if any conditions have been violated

c. Any officer or employee designated by the Secretary

shall have access to any factory or establishment, toascertain whether or not conditions of thepermit are being complied with; if deniedaccess, permit will be suspended until access isgiven by the operator


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Tolerances for Poisonous Ingredients

in FoodCoal-Tar Color for food

(a) Any poisonous or deleterious substance addedto any food, shall be deemed to be unsafeexcept when such substance is required orcannot be avoided in its production ormanufacture. The Secretary will regulatewhat quantities are safe and unsafe

And shall promulgate regulations providing forthe listing of coal-tar colors which are harmlessand suitable for use in food.


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Adulterated drug-Alysena 28

CHAPTER VIIDrugs and Devices

i


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Devices


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Exemption in Case of Drugs and

DevicesSec. 20. (a) The Secretary can promulgate regulations

exempting from any labeling or packaging requirementof this act drugs and devices which are not adulteratedor misbranded

Must bear statement Caution: Food, Drug andCosmetics Law prohibits dispensing withoutprescription

Drugs that are habit formingHave toxicity or potentially harming effect or

method of use is not safe except under supervisionof a practitioner licensed to administer the drug

Are new drugs whose application are limited to

investigational use and dispensed only uponprescription


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New Drugs

Sec. 21. (a) No person shall manufacture, sell,offer for sale or transfer any new drug, unless anapplication filed is effective with respect to suchdrug.(b) To apply, one must submit to the Secretary:

(1) full reports of investigations which have beenmade to show whether or not such drug is safe foruse(2) a full list of the articles used as components ofsuch drug; (3) a full statement of the compositionof such drug;(4) a full description of the methods used in andthe facilities and controls used for themanufacture, processing, and packing of suchdrug;(5) such samples of such drug and of the articleused as components thereof as the Secretary may


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New Drugs(c) Secretary has 180 days to:

Approve application

Give the applicant notice of an opportunity for ahearing of approval

After fair evaluation, Secretary can deny

application if application does not have all therequirements or if the drug is not safe based onclinical trials


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CHAPTER IXCertification of Drugs containing Penicillin,Streptomycin, Chlortetracycline,

Chloramphenicol or BacitracinSec. 22. (a) The Secretary shall certify

batches of drugs composed of any kind ofpenicillin, streptomycin, chlortetracycline,

chloramphenicol, bacitracin, or any otherantibiotic drug, or any derivative thereof,based on identity, strength, qualityand purity, as the Secretary prescribes to

insure safety and efficacy of use

Anti-biotic drug: any drug produced bymicro-organism and has the capacity to

inhibit or destroy micro-organims in dilute


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Questions?

Food, Drug, And Cosmetics Act 2013

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